A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT)

September 1, 2015 updated by: OSI Pharmaceuticals

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.

Study Type

Interventional

Enrollment (Actual)

1252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1272AAA
        • Hospital de Rehabilitación Respiratoria María Ferrer
      • Mendoza, Argentina, M5500AYB
        • COIR
      • Rosario, Santa Fe, Argentina, S2001SBL
        • Hospital Espanol de Rosario
      • Santa Fé, Argentina, S3000FFU
        • ISIS Centro Especializado De Luce S.A.
  • Australia
      • Adelaide, Australia, 5067
        • Respiratory Clinical Trials Pty., Ltd
      • Ashford, Australia, SA 5037
        • Ashford Cancer Centre
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • East Bentleigh, Victoria, Australia, 3165
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Universitaetsklinikum Innsbruck
      • Linz, Austria, 4021
        • Allgemeines Krankenhaus der Stadt Linz
      • Salzburg, Austria, 5020
        • Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
      • Wien, Austria, 1130
        • Krankenhaus Hietzing
      • Wien, Austria, 1090
        • Akh Wien
      • Wien, Austria, 1140
        • SMZ Baumgartner Hoehe - Otto Wagner Spital
      • Wien, Austria, A-1140
        • SMZ Baumgartner Höhe - Otto- Wagner-Spital
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Charleroi, Belgium, 6000
        • Le Grand Hôpital de Charleroi
      • La Louvière, Belgium, 7100
        • Centre Hospitalier Jolimont-Lobbes
  • Canada
      • Toronto, Canada, M6R 1B5
        • St. Joseph's Health Centre
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Center of Southeastern Ontario at Kingston General Hospital
      • Mississauga, Ontario, Canada, L5M 2N1
        • Trillium Health Partners - Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional cancer Centre at Southlake
      • Oshawa, Ontario, Canada, L1G 2B9
        • RS MacLaughlin Durham Regional Cancer Centre
      • Sault Ste Marie, Ontario, Canada, P6A 5K7
        • Sault Area Hospital
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Science Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Dept. of Oncology
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 370 87
        • Nemocnice Ceske Budejovice, a.s.
      • Ostrava-Poruba, Czech Republic, 70852
        • Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
      • Praha, Czech Republic, 8 18081
        • FN Bulovka Klinika plincni a hrrudni chirurgie
  • France
      • Bayonne, France, 64100
        • Centre d'oncologie et de radiothérapie du Pays Basque
      • Brest cedex, France, 29609
        • C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
      • Caen Cedex, France, 14033
        • CHU de Caen - Service de pneumologie
      • Clermont-Ferrand cedex 1, France, 63003
        • CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
      • Lyon cedex 04, France, 69317
        • Hopital De La Croix-Rousse Service de Pneumologie
      • Marseille cedex 9, France, 13273
        • Institut Paoli-Calmettes
      • PARIS cedex 14, France, 75014
        • Fondation Hôpital Saint Joseph
      • Paris, France, 75012
        • Hôpital de Tenon
      • Perpignan, France, 66000
        • Centre Catalan d'Oncologie
      • Rennes cedex 9, France, 35033
        • CHU - Hopital Pontchaillou - Service de pneumologie
      • Saint Priest en Jarez, France, 42271
        • Institut de Cancerologie de La Loire
      • Vandoeuvre-lès-Nancy Cedex, France, 54511
        • Hôpital de Brabois
    • Cedex 9
      • Toulouse, Cedex 9, France, 31059
        • CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka
      • Berlin, Germany, 14165
        • Helios Klinikum Emil von Behring GmbH
      • Bochum, Germany, 44791
        • Augusta-Krankenanstalt Bochum
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig
      • Essen, Germany, 45122
        • Universitaetsklinikum Essen
      • Frankfurt/Main, Germany, 60488
        • Krankenhaus Nordwest
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf
      • Göttingen, Germany, 37075
        • Universitätsklinikum Göttingen
      • Halle (Saale), Germany, 06120
        • Städtisches Krankenhaus Martha-Maria, Halle-Dölau
      • Hamburg, Germany, 21075
        • Asklepios Klinik Harburg
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg
      • Hemer, Germany, 58675
        • Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
      • Karlsruhe, Germany, 76137
        • St. Vincentius-Kliniken Karlsruhe
      • Lübeck, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein
      • Mainz, Germany, 55131
        • Universitätsklinikum Mainz
      • Muenchen-Gauting, Germany, 82131
        • Asklepios Klinikum Gauting
      • Oldenburg, Germany, 26121
        • Pius Hospital Oldenburg
      • Villingen-Schwenningen, Germany, 78050
        • Schwarzwald-Baar Klinikum
  • Greece
      • Athens, Greece, 15562
        • IASO General Hospital of Athens
      • Thessaloniki, Greece, 54603
        • "Papageorgiou" General Hospital of Thessaloniki
      • Thessaloniki, Greece, 57010
        • "G. Papanikolaou" General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika
      • Deszk, Hungary, 6772
        • Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
      • Pécs, Hungary, 7623
        • Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korhaz
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
  • Italy
      • Ancona, Italy, 60020
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
      • Bologna, Italy, 40139
        • Ospedale Bellaria
      • Catania, Italy, 95100
        • Ospedale Garibaldi Nesima
      • Genova, Italy, 16132
        • Istituto Nazionale per la Ricerca e la Cura del Cancro
      • Parma, Italy, 43100
        • Azienda Ospedaliero- Universitaria di Parma
      • Perugia, Italy, 06132
        • Ospedale S. Maria Della Misericordia
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
  • Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of, 442-723
        • Saint Vincent's Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon Medical School Ghil Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei Univ. College of Medicine
  • Poland
      • Lublin, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Poznan, Poland, 60-569
        • Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
      • Szczecin, Poland, 70-891
        • Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
      • Warsaw, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
      • Wroclaw, Poland, 53-439
        • Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
  • Romania
      • Bucuresti, Romania, 022328
        • Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
      • Bucuresti, Romania, 022328
        • Institutul Oncologic Al. Trestioreanu
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
      • Iasi, Romania, 700106
        • Centrul de Oncologie Medicala
      • Sibiu, Romania, 550245
        • Spitalul Clinic Judetean Sibiu
    • Bihor
      • Oradea, Bihor, Romania, 410032
        • Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
    • Dolj
      • Craiova, Dolj, Romania, 200535
        • Oncoloab SRL
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
      • Kemerovo, Russian Federation, 650036
        • State Healthcare Institution "Regional Clinical Oncology Dispensary"
      • Krasnodar, Russian Federation, 350086
        • State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
      • Moscow, Russian Federation, 105229
        • State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
      • Moscow, Russian Federation, 115478
        • Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
      • Saint-Petersburg, Russian Federation, 197022
        • State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"
      • Saint-Petersburg, Russian Federation, 197758
        • Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
      • Saint-Petersburg, Russian Federation, 198255
        • Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
      • Tomsk, Russian Federation, 634050
        • Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
      • Yaroslavl, Russian Federation, 150040
        • State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28033
        • Hospital Oncologico MD Anderson
      • Málaga, Spain, 29010
        • Hospital Carlos Haya
      • Málaga, Spain, 29010
        • Hospital Clínico Virgen de la Victoria
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Sevilla, Spain, 41700
        • Hospital Universitario de Valme
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud de Toledo
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Barcelona
      • L' Hospitalet de Llobregat, Barcelona, Spain, 08907
        • ICO (Institut Catalá d´Oncología)
      • Manresa, Barcelona, Spain, 08243
        • Fundacio Althaia
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro Majadahonda
  • Taiwan
      • Changhua, Taiwan, 500-06
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 833
        • Chang Gung Medical Foundation
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung memorial hospital
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Guildford, United Kingdom, GU2 7XX
        • The Royal Surrey County Hospital NHS Trust
      • Lecester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • St James' Institute of Oncology, Bexley Wing, St James' University Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Science
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • Duarte, California, United States, 91010
        • City of Hope Nat'l Medical Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC/ Norris Comprehensive Cancer Center
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital Presbyterian
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Center at Desert Regional Medical Center
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group, LLC
      • San Francisco, California, United States, 94143-1770
        • University of California, San Francisco Comprehensive Cancer Center
      • South Pasadena, California, United States, 91030
        • City of Hope Medical Group (COHMG)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center- Aurora
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Center
      • Colorado Springs, Colorado, United States, 80907
        • Penrose St. Francis Health Services
      • Colorado Springs, Colorado, United States, 80909
        • Rocky Mountain Cancer Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers- Rose
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, United States, 80120-4413
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Center-Sky Ridge
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, United States, 80138
        • Rocky Mountain Cancer Center-Parker
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Sharon, Connecticut, United States, 06069
        • Smilow Cancer Hospital Care Center
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology, P.C.
      • Torrington, Connecticut, United States, 06790
        • Smilow Cancer Hospital Care Center
    • Florida
      • Hudson, Florida, United States, 34667
        • Florida Cancer Institute-New Hope
      • Jacksonville, Florida, United States, 32204
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32216
        • Cancer Specialists of North Florida
      • Lakeland, Florida, United States, 33805
        • Watson Clinic LLP
      • Miami, Florida, United States, 33176
        • Advanced Medical Specialties
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Institute- New Hope
      • Orlando, Florida, United States, 32806
        • Florida Cancer Specialists
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Peachtree Hematology-Oncology Consultants, P.C.
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care, PC
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute
      • Meridian, Idaho, United States, 83642
        • Mountain States Tumor Institute
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
      • Twin Falls, Idaho, United States, 83301
        • Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago, Section of Hematology/Oncology
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology Hematology Assoc., LTD
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana University Health
      • Fishers, Indiana, United States, 46037
        • Indiana University Health
      • Greenfield, Indiana, United States, 46140
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46219
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46227
        • Indiana University Health
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare, Inc.
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Leonard J. Chabert Medical Center
    • Maine
      • Brewer, Maine, United States, 04412
        • Cancer Care of Maine
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center's Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology Hematology, P.A.
      • Edina, Minnesota, United States, 55435-2150
        • Minnesota Oncology Hematology, P.A.
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, P.A.
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A.
      • St. Paul, Minnesota, United States, 55102-2389
        • Minnesota Oncology Hematology
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • St. Joseph, Missouri, United States, 64507
        • Heartland Regional Medical Center d/b/a Heartland Clinic
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • St. Francis Cancer Treatment Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • NH Oncology-Hematology PA (Co)
      • Hooksett, New Hampshire, United States, 03106
        • NH Oncology-Hematology PA
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Science Center
      • Santa Fe, New Mexico, United States, 87505
        • Christus St. Vincent Regional Cancer Center
    • New York
      • Brockport, New York, United States, 14420
        • Interlakes Oncology Hematology, PC
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Canadaigua, New York, United States, 14424
        • Interlakes Oncology Hematology, PC
      • Geneva, New York, United States, 14456
        • Interlakes Oncology Hematology, PC
      • New Rochelle, New York, United States, 10801
        • Advanced Oncology Associates
      • New York, New York, United States, 10065
        • The New York Presbyterian-Weill Medical College of Cornell University
      • Rochester, New York, United States, 14623
        • Interlakes Oncology Hematology, PC
      • Rochester, New York, United States, 14626
        • Interlakes Oncology Hematology, PC
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
      • Hickory, North Carolina, United States, 28602
        • Carolina Oncology Specialists PA
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Hematology Oncology Associates
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Hematology Oncology Associates
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital/ North Canton Medical Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hopsitals of Cleveland
      • Columbus, Ohio, United States, 43228
        • Hematology Oncology Consultants Inc.
    • Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, United States, 97225
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, United States, 97213
        • Earle A Chiles Research Institute
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists, PC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Cancer Care Associates - Medical Oncology
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Assoc., PA
      • Easley, South Carolina, United States, 29640
        • Cancer Centers of the Carolinas
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas
      • Seneca, South Carolina, United States, 29672
        • Cancer Centers of the Carolinas, Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Cancer Centers of the Carolinas
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Medical Center
      • Germantown, Tennessee, United States, 38138
        • Bostin Baskin Cancer Foundation
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists
      • Memphis, Tennessee, United States, 38120
        • West Clinic
      • Memphis, Tennessee, United States, 38119
        • Family Cancer Center Foundation, Inc.
      • Memphis, Tennessee, United States, 38104
        • Bostin Baskin Cancer Foundation
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology, P.A. - Amarillo
      • Beaumont, Texas, United States, 77702-1449
        • Texas Oncology Beaumont
      • Dallas, Texas, United States, 75246
        • Baylor Charles A Sammons Cancer Center
      • Dallas, Texas, United States, 75230-2510
        • Texas Oncology Texas Cancer Center at Medical City
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology - Flower Mound
      • Fort Worth, Texas, United States, 76132
        • Texas Oncology Southwest Forth Worth
      • Ft. Worth, Texas, United States, 76104
        • Texas Oncology, Fort Worth
      • Garland, Texas, United States, 75042-5788
        • Texas Oncology, Garland
      • New Braunfels, Texas, United States, 78131
        • Cancer Care Centers of South Texas - HOAST
      • Paris, Texas, United States, 75460-5004
        • Texas Oncology - Paris
      • Plano, Texas, United States, 75075-7787
        • Texas Oncology - Plano East
      • San Antonio, Texas, United States, 78229
        • Cancer Care Centers of South Texas-HOAST
      • Tyler, Texas, United States, 75702
        • Texas Oncology -Tyler
      • Waco, Texas, United States, 76712
        • Texas Oncology Cancer Care and Research Center
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
      • Christiansburg, Virginia, United States, 24073
        • Onc and Hem Associates of SW VA, Inc.
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
      • Salem, Virginia, United States, 24153
        • Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
      • Wytheville, Virginia, United States, 24382
        • Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, United States, 98109
        • Univ. of Washington/ Seattle Cancer Care Alliance
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest-North
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest-Valley
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C.
      • Vancouver, Washington, United States, 98686
        • Northwest Cancer Specialist, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests
  • Patients may have up to 4 cycles of chemotherapy after surgery
  • Complete removal of the tumor by surgery

  • Able to start drug under the following timelines:

    • 6 months from the day of surgery for patients who get chemotherapy
    • 3 months from the day of surgery for those who do not get chemotherapy
  • Confirmed diagnosis of Stage IB-IIIA NSCLC
  • Patients must be accessible for follow-up visits

Exclusion Criteria:

  • History of prior radiotherapy for NSCLC either before or after surgery
  • History of heart disease or uncontrolled heart arrhythmias within the previous year
  • History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug
  • History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
  • Patients who have received chemotherapy for NSCLC before surgery
  • Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib
Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Drug: Erlotinib
150 mg tablet
Other Names:
  • Tarceva
  • OSI-774
Placebo Comparator: Placebo
Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Drug: Placebo
Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Disease Free Survival (DFS)
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).
DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Overall Survival (OS)
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)

Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.

Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)

Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.

Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)
Number of Participants With Adverse Events (AEs)
Time Frame: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.

An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.

An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.

A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug.
From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-774-302
  • 2005-001747-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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